Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| IRCCS San Raffaele | OTHER |
Not provided
Not provided
Not provided
Not provided
The study aims to investigate the impact of 2 nutritional patterns on high-frequency episodic migraine. Subjects enrolled will be randomized in two arms: a) very-low-calorie-ketogenic-diet (VLCKD), b) hypocaloric balanced non ketogenic-diet (HBD).
This randomized controlled trial aims to:
All the eligible subjects (please, see the inclusion and exclusion criteria), will be randomized in two groups. Both VLCKD or HBD will be undergone to 24 weeks of diet. For VLCKD- group, the ketogenic period will be maintained for 8 weeks. In the following four weeks, carbohydrates are gradually reintroduced, starting from foods with the lowest glycemic index (fruit, dairy products), followed by foods with moderate and high glycemic index (bread, pasta and cereals). The goal is to achieve a hypocaloric balanced diet (HBD), as well as the controlled group. From the 12th week to the 24 th week, all subjects enrolled will continue follow-up with HBD. Periodically, subjects will be monitored through physical examination (anthropometric measurements, blood pressure, heart rate, etc.) and laboratory analysis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very-low-calorie-ketogenic-diet | Experimental | Very-low-calorie-ketogenic-diet (VLCKD) for 12 weeks; hypocaloric-balanced-diet (HBD) |
|
| Hypocaloric-balanced-diet | Active Comparator | Hypocaloric-balanced-diet (HBD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| very-low-calorie-ketogenic-diet | Dietary Supplement | VLCKD-group will undergone to VLCKD for 8 weeks. VLCKD is based on protein preparations of high biological value. Total daily energy intake is < 800 kcal.Daily carbohydrate intake is lower than 30 g/day, while daily protein intake is approximately 1.2-1.5 g/kg of ideal body weight. The following four weeks, carbohydrates are gradually reintroduced, starting from foods with the lowest glycemic index (fruit, dairy products), followed by foods with moderate and high glycemic index (bread, pasta and cereals). The goal is to achieve a hypocaloric balanced diet (HBD), as well as the controlled group. From the 12th week to the 24 th week, all subjects enrolled will continue follow-up with HBD. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in migraine frequency | Migraine Disability Assessment Score Questionnaire (MIDAS) is used in order to evaluate how severity migraine affects patient's life. MIDAS score: 0-25 | at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7) |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of migraine episode on daily activities | Headache Impact Test (HIT-6) is used in order to determine how severely migraine impacts on daily activities. HIT-6 total score: 36-78 | at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Piero Barbanti, Prof. | IRCCS San Raffaele Pisana, 00163 Rome-Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Pisana | Rome | 00163 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28931491 | Background | GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17. | |
| 17261680 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D015431 | Weight Loss |
| D050177 | Overweight |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| hypocaloric-balanced-diet | Other | HBD-group will undergone to hypo caloric balanced diet for 24 weeks. Total daily average energy intake is 1500-1600 kcal/day. 30% of total daily energy is composed by lipids (10% MUFA, 10% PUFA, 10% SFA), 55% carbohydrates, while daily protein intake is approximately 0.8-1.5 g /kg of ideal body weight. |
|
| Weight loss |
Physical examination will be carried out in each visit. Weight will be detected |
| at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7) |
| Change in immune system parameters | Immune system plays a key role in overweight subjects susceptibility to inflammatory diseases. Lymphocyte subpopulation will be studied before and after VLCKD or HBD through blood tests. | at the screening (V1),at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) |
| Health-related quality of life | Health Survey-36 (SF-36) is used in order to evaluate the impact of migraine on quality of life. SF-36 score: The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. | at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) |
| change in analgesic consumption | On migraine-diary, subjects will reported analgesic consumption during diet-treatment | through study completion, an average of 24 weeks |
| Measure of pain | Visual analogue scale (VAS) is used in order to evaluate pain intensity. VAS score: 0-10 | at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) |
| Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21. |
| 17515549 | Background | Bigal ME, Lipton RB, Holland PR, Goadsby PJ. Obesity, migraine, and chronic migraine: possible mechanisms of interaction. Neurology. 2007 May 22;68(21):1851-61. doi: 10.1212/01.wnl.0000262045.11646.b1. |
| 20673279 | Background | Bond DS, Roth J, Nash JM, Wing RR. Migraine and obesity: epidemiology, possible mechanisms and the potential role of weight loss treatment. Obes Rev. 2011 May;12(5):e362-71. doi: 10.1111/j.1467-789X.2010.00791.x. |
| 27012149 | Background | Peterlin BL, Sacco S, Bernecker C, Scher AI. Adipokines and Migraine: A Systematic Review. Headache. 2016 Apr;56(4):622-44. doi: 10.1111/head.12788. Epub 2016 Mar 25. |
| 26641646 | Background | Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5. |
| 25063307 | Background | Basciani S, Costantini D, Contini S, Persichetti A, Watanabe M, Mariani S, Lubrano C, Spera G, Lenzi A, Gnessi L. Safety and efficacy of a multiphase dietetic protocol with meal replacements including a step with very low calorie diet. Endocrine. 2015 Apr;48(3):863-70. doi: 10.1007/s12020-014-0355-2. Epub 2014 Jul 26. |
| 28721154 | Background | Ellulu MS, Patimah I, Khaza'ai H, Rahmat A, Abed Y. Obesity and inflammation: the linking mechanism and the complications. Arch Med Sci. 2017 Jun;13(4):851-863. doi: 10.5114/aoms.2016.58928. Epub 2016 Mar 31. |
| 23228828 | Background | Lutas A, Yellen G. The ketogenic diet: metabolic influences on brain excitability and epilepsy. Trends Neurosci. 2013 Jan;36(1):32-40. doi: 10.1016/j.tins.2012.11.005. Epub 2012 Dec 8. |
| 26844268 | Background | Klosinski LP, Yao J, Yin F, Fonteh AN, Harrington MG, Christensen TA, Trushina E, Brinton RD. White Matter Lipids as a Ketogenic Fuel Supply in Aging Female Brain: Implications for Alzheimer's Disease. EBioMedicine. 2015 Nov 3;2(12):1888-904. doi: 10.1016/j.ebiom.2015.11.002. eCollection 2015 Dec. |
| 25101284 | Background | Paoli A, Bianco A, Damiani E, Bosco G. Ketogenic diet in neuromuscular and neurodegenerative diseases. Biomed Res Int. 2014;2014:474296. doi: 10.1155/2014/474296. Epub 2014 Jul 3. |
| 18281154 | Background | de Almeida Rabello Oliveira M, da Rocha Ataide T, de Oliveira SL, de Melo Lucena AL, de Lira CE, Soares AA, de Almeida CB, Ximenes-da-Silva A. Effects of short-term and long-term treatment with medium- and long-chain triglycerides ketogenic diet on cortical spreading depression in young rats. Neurosci Lett. 2008 Mar 21;434(1):66-70. doi: 10.1016/j.neulet.2008.01.032. Epub 2008 Jan 19. |
| 16807920 | Background | Bough KJ, Wetherington J, Hassel B, Pare JF, Gawryluk JW, Greene JG, Shaw R, Smith Y, Geiger JD, Dingledine RJ. Mitochondrial biogenesis in the anticonvulsant mechanism of the ketogenic diet. Ann Neurol. 2006 Aug;60(2):223-35. doi: 10.1002/ana.20899. |
| 29321682 | Background | Mattson MP, Moehl K, Ghena N, Schmaedick M, Cheng A. Intermittent metabolic switching, neuroplasticity and brain health. Nat Rev Neurosci. 2018 Feb;19(2):63-80. doi: 10.1038/nrn.2017.156. Epub 2018 Jan 11. |
| 15911785 | Background | Waeber C, Moskowitz MA. Migraine as an inflammatory disorder. Neurology. 2005 May 24;64(10 Suppl 2):S9-15. doi: 10.1212/wnl.64.10_suppl_2.s9. No abstract available. |
| 28178565 | Background | Puchalska P, Crawford PA. Multi-dimensional Roles of Ketone Bodies in Fuel Metabolism, Signaling, and Therapeutics. Cell Metab. 2017 Feb 7;25(2):262-284. doi: 10.1016/j.cmet.2016.12.022. |
| 21939657 | Background | Jeong EA, Jeon BT, Shin HJ, Kim N, Lee DH, Kim HJ, Kang SS, Cho GJ, Choi WS, Roh GS. Ketogenic diet-induced peroxisome proliferator-activated receptor-gamma activation decreases neuroinflammation in the mouse hippocampus after kainic acid-induced seizures. Exp Neurol. 2011 Dec;232(2):195-202. doi: 10.1016/j.expneurol.2011.09.001. Epub 2011 Sep 14. |
| 28521671 | Background | Zhang Y, Xu J, Zhang K, Yang W, Li B. The Anticonvulsant Effects of Ketogenic Diet on Epileptic Seizures and Potential Mechanisms. Curr Neuropharmacol. 2018;16(1):66-70. doi: 10.2174/1570159X15666170517153509. |
| 22567104 | Background | Kim DY, Hao J, Liu R, Turner G, Shi FD, Rho JM. Inflammation-mediated memory dysfunction and effects of a ketogenic diet in a murine model of multiple sclerosis. PLoS One. 2012;7(5):e35476. doi: 10.1371/journal.pone.0035476. Epub 2012 May 2. |
| 19049594 | Background | Yudkoff M, Daikhin Y, Horyn O, Nissim I, Nissim I. Ketosis and brain handling of glutamate, glutamine, and GABA. Epilepsia. 2008 Nov;49 Suppl 8(Suppl 8):73-5. doi: 10.1111/j.1528-1167.2008.01841.x. |
| 24598400 | Background | Di Lorenzo C, Curra A, Sirianni G, Coppola G, Bracaglia M, Cardillo A, De Nardis L, Pierelli F. Diet transiently improves migraine in two twin sisters: possible role of ketogenesis? Funct Neurol. 2013 Oct-Dec;28(4):305-8. |
| 25156013 | Background | Di Lorenzo C, Coppola G, Sirianni G, Di Lorenzo G, Bracaglia M, Di Lenola D, Siracusano A, Rossi P, Pierelli F. Migraine improvement during short lasting ketogenesis: a proof-of-concept study. Eur J Neurol. 2015 Jan;22(1):170-7. doi: 10.1111/ene.12550. Epub 2014 Aug 25. |
| 27245682 | Background | Di Lorenzo C, Coppola G, Bracaglia M, Di Lenola D, Evangelista M, Sirianni G, Rossi P, Di Lorenzo G, Serrao M, Parisi V, Pierelli F. Cortical functional correlates of responsiveness to short-lasting preventive intervention with ketogenic diet in migraine: a multimodal evoked potentials study. J Headache Pain. 2016;17:58. doi: 10.1186/s10194-016-0650-9. Epub 2016 May 31. |
| 6761185 | Background | Fery F, Bourdoux P, Christophe J, Balasse EO. Hormonal and metabolic changes induced by an isocaloric isoproteinic ketogenic diet in healthy subjects. Diabete Metab. 1982 Dec;8(4):299-305. |
| 37794395 | Derived | Caprio M, Moriconi E, Camajani E, Feraco A, Marzolla V, Vitiello L, Proietti S, Armani A, Gorini S, Mammi C, Egeo G, Aurilia C, Fiorentini G, Tomino C, Barbanti P. Very-low-calorie ketogenic diet vs hypocaloric balanced diet in the prevention of high-frequency episodic migraine: the EMIKETO randomized, controlled trial. J Transl Med. 2023 Oct 4;21(1):692. doi: 10.1186/s12967-023-04561-1. |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |